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New drugs and medical devices cannot be sold to US customers before being approved by the Food and Drug Administration (FDA). This hurdle makes it harder and more expensive for companies to bring new products to market, but the point is obviously to safeguard the public.

Innovative and higher risk products have to be proven safe through clinical trials, the cost of which can run into tens of millions of dollars - because the need for reliable (statistically significant) data requires experiments with sufficiently large patient populations. In medical devices, the most important concept in connection with an FDA application is substantial equivalence, a comparison of moderate risk devices. If the FDA deems a device product substantially equivalent to one or more already cleared devices, then it will not require a clinical trial before putting it on the market.

Richard Tharin

The FDA is always under pressure to process applications swiftly while also protecting the public. With changing politics and differing interpretations of rules, the FDA has to adapt to the times. Currently, some want to do away with the concept of substantial equivalence, arguing that it provides loopholes for unsafe products to slip through and endanger the public. Others want to reduce the onerous burden that the FDA application process puts on innovative companies.
Regulatory affairs is a topic so complex that it is now an independent academic discipline, with several universities offering online M.S. programs.
Richard Tharin is a regulatory affairs specialist consulting to pharmaceutical and medical device companies in need of regulatory approval. He works with companies large and small, and also advises investors on new projects' potential regulatory path.

In his judgment, the four most important things to do in connection with an application to the FDA are the following:

Communicate openly with the FDA and other stakeholders

Decide on story to tell

Follow up

Be ethical

Companies obviously need to hold their cards close to their chest in a competitive environment. Sharing information relating to competitive advantage with anyone, including the FDA, is not done lightly. The FDA is basically a professional organization but human errors will take place in any organization. Large companies can be overly concerned about this risk, sometimes to the point of paranoia. This can lead them to minimize the information given to the FDA.

Richard feels this is throwing the baby out with the bath water. FDA employees work hard to do the right thing, and you are more likely to succeed if you work with them and not against them. The FDA has guidelines for the employees to follow but because of the above mentioned constant changes in the environment, the interpretation of rules is always subject to change, and on the outside this can give the impression of a lack of transparency. Parsimony with information is not the best way to deal with this issue.

Deciding on a story to tell is both about clarity of purpose inwardly and clear signaling outwardly. An FDA application should describe a clear path to commercialization, which medical markets to serve, and how the new product helps patients and physicians. For example, while the FDA guidelines do not prescribe that attention be paid to the reimbursement strategy (to what extent health insurance companies will pay for the new product), the FDA employees will consider it, because they are concerned with the new product's public health impact.

Following up after an approval by the FDA matters also, and it has to be planned early. It is best to be proactive about adverse events which at any rate have to be reported to the FDA within 10 days. Eagerness to comply means the FDA will work with you rather than look askance at you. It is also useful to monitor where incompatibility with other drugs can become an issue. Being proactive helps in your relationship with the FDA and it can lead to opportunities for growth.

Communicating openly and complying eagerly tally nicely with Richard Tharin's fourth and most important recommendation: be ethical. This means actually helping as opposed to making a quick buck. If you have an ethical center based on health care promotion, collaboration with your surroundings becomes easier. The FDA guidelines do not refer specifically to social justice or the common weal, but unconsciously FDA employees care and see themselves as a force for good. If you genuinely promote health you get politicians on your side, and the key opinion leaders. Insurance companies will become more inclined to accommodate you.

Being ethical is good business.

Arne Hessenbruch is a Danish expat and the founder of Boston Denmark Partnerships, where he connects Danish companies with an interest in doing business in Boston.

This blog is not written or edited by Boston.com or the Boston Globe.
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